2018-27098: Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
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The Food and Drug Administration (FDA, the Agency, or we) is announcing the withdrawal of the proposed rule on "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" that published in the Federal Register of November 13, 2013. FDA is taking this action in light of concerns expressed by commenters and considerations regarding Agency resources. FDA is continuing to consider ways to improve the communication of important, newly acquired drug safety information to healthcare providers and the public and to facilitate efforts to keep drug product labeling up to date throughout the product lifecycle.
The agency’s own summary, as published.
What this changes
Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
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